International Agency for Research on Cancer (IARC) - Summaries & Evaluations

(Group 3)

For definition of Groups, see Preamble Evaluation.

VOL.: 50 (1990) (p. 277)

CAS No.: 54-31-9
Chem. Abstr. Name: 5-(Aminosulfonyl)-4-chloro-2-[(2-furanylmethyl)-amino]-benzoic acid

5. Summary of Data Reported and Evaluation

5.1 Exposure data

Furosemide is a diuretic. It has been used extensively since 1964 in the treatment of oedema and hypertension.

5.2 Experimental carcinogenicity data

Furosemide was tested for carcinogenicity by oral administration in one strain of mice and one strain of rats. A small increase in the incidence of mammary gland carcinomas was observed in female mice. No increase in the incidence of tumours was seen in rats.

5.3 Human carcinogenicity data

In one hypothesis-generating study in which many drugs were screened for possible carcinogenicity, associations with furosemide use were observed for cancers of the lung and of all sites combined, which could have been accounted for by smoking and/or chance.

5.4 Other relevant data

The data are inadequate to assess the effects of furosemide on human reproduction. In rats, the drug induces skeletal anomalies.

Furosemide is metabolized by mouse and human liver microsomes and binds covalently to proteins. Renal tubular hyperplasia and hepatic centrilobular necrosis have been observed after administration of large doses of furosemide to mice.

Studies on the induction by furosemide of chromosomal aberrations in mice were inconclusive. Reports of studies on chromosomal aberrations in human cells in vitro gave conflicting results; it induced chromosomal damage in hamster cells. Furosemide did not induce sister chromatid exchange in human cells in vitro; one study gave questionably positive results for sister chromatid exchange in Chinese hamster cells and for gene mutation in mouse lymphoma cells. The urine of rats treated with this drug did not induce gene conversion in Saccharomyces cerevisiae. It was not mutagenic to Salmonella typhimurium.

5.5 Evaluation

There is inadequate evidence for the carcinogenicity of furosemide in humans.

There is inadequate evidence for the carcinogenicity of furosemide in experimental animals.

Overall evaluation

Furosemide is not classifiable as to its carcinogenicity to humans (Group 3).

For definition of the italicized terms, see Preamble Evaluation.

Synonyms for furosemide

Synonyms for multi-ingredient preparations containing furosemide

Last updated: 11 November 1997

    See Also:
       Toxicological Abbreviations